Terazosin transdermal device and methods

Abstract

A method of effectively treating benign prostatic hypertension in humans is achieved by administering terazosin via a transdermal formulation. Preferably, the transdermal formulation is applied to the skin of the patient and maintained in contact with the skin for at least about 24 hours, and preferably for about 3 to about 8 days.

Description

[0001] This application claims the benefit of U.S. Provisional No. 60 / 242,513, filed Oct. 23, 2000, hereby incorporated by reference.[0002] It is the intent of all sustained-release pharmaceutical preparations to provide a longer period of pharmacologic effect after the administration of a drug than is ordinarily experienced after the administration of immediate release preparations of the same drug. Such longer periods of efficacy can provide many inherent therapeutic benefits that are not achieved with corresponding immediate release preparations. The benefits of prolonged analgesia afforded by sustained release oral preparations have become universally recognized and oral sustained-release preparations are commercially available.[0003] Another approach to sustained delivery of a therapeutically active agent is transdermal delivery systems, such as transdermal patches. Generally, transdermal patches contain a therapeutically active agent, a reservoir or matrix containing the activ...

AI Technical Summary

Benefits of technology

[0014] It is an object of certain embodiments of the present invention to provide a method for treating patient suffering from benign prostatic hypertrophy which achieves prolonged and effective management of this condition, while at the same time provides the opportunity to reduce possible side effects, e.g., which patients may experience when subjected to prolonged oral therapy.

[0182] In vitro skin permeation studies with cadaver skin quantitatively predict the pharmacokinetics and extent of drug absorption from the transdermal delivery dosage form. Matching in vitro skin donors to the in vivo population improves the correlation. Further improvements in this correlation are achieved by matching application sites.

Problems solved by technology

Benign adenomatous hyperplasia of the periurethral prostate gland is commonly seen in men over the age of 50, causing variable degrees of bladder outlet obstruction.

As the lumen of the prostatic urethra is compromised, the outflow of urine is progressively obstructed.

Prolonged obstruction, even though incomplete, can compromise renal function.

Symptoms of bladder outlet obstruction include progressive urinary frequency, urgency, and nocturia due to incomplete emptying and rapid refilling of the bladder.

Terazosin therapy can cause other adverse effects including rash, pruritus, urinary frequency, incontinence, blurred vision, xerostomia (dry mouth), vomiting, constipation, diarrhea, liver-function test abnormalities, diaphoresis, dyspnea, fever, and arthralgia.